Metronidazole Gel

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Metronidazole Gel Recall

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Side Effects & Adverse Reactions

Convulsive Seizures and Peripheral Neuropathy:

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole vaginal gel therapy. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases.

Psychotic Reactions:

Psychotic reactions have been reported in alcoholic patients who were using oral metronidazole and disulfiram concurrently. Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last two weeks.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.

Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

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History

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Other Information

Metronidazole Vaginal Gel is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure:

Metronidazole Vaginal Gel is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 934P, edetate disodium, methylparaben, propylparaben, propylene glycol, and sodium hydroxide.

Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole.

Sources

Metronidazole Gel Manufacturers

Oceanside Pharmaceuticals

Metronidazole Gel | Oceanside Pharmaceuticals

The recommended dose is one applicator full of Metronidazole Vaginal Gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once-a-day dosing, Metronidazole Vaginal Gel should be administered at bedtime.

No Recall
Remedyrepack Inc.

Metronidazole Gel | Remedyrepack Inc.

The recommended dose is one applicator full of metronidazole vaginal gel USP, 0.75% (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, metronidazole vaginal gel USP, 0.75% should be administered at bedtime.

No Recall
Remedyrepack Inc.

Metronidazole Gel | Remedyrepack Inc.

The recommended dose is one applicator full of metronidazole vaginal gel USP, 0.75% (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, metronidazole vaginal gel USP, 0.75% should be administered at bedtime.

No Recall
Prasco Laboratories

Metronidazole Gel | Prasco Laboratories

The recommended dose is one applicator full of Metronidazole Vaginal Gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole Vaginal Gel should be administered at bedtime.

No Recall
Sandoz Inc.

Metronidazole Gel | Sandoz Inc.

The recommended dose is one applicator full of metronidazole vaginal gel USP, 0.75% (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, metronidazole vaginal gel USP, 0.75% should be administered at bedtime.

No Recall
Preferred Pharmaceuticals, Inc

Metronidazole Gel | Mikah Pharma, Llc

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.

Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Metronidazole Gel | Taro Pharmaceuticals U.s.a., Inc.

Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel.

No Recall
Sandoz Inc.

Metronidazole Gel | Sandoz Inc.

Apply and rub in a thin film of metronidazole topical gel USP, 0.75%, twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole topical gel USP, 0.75%. Patients may use cosmetics after application of metronidazole topical gel USP, 0.75%.

No Recall
Rebel Distributors Corp

Metronidazole Gel | Rebel Distributors Corp

Apply and rub in a thin film of metronidazole topical gel USP, 0.75%, twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole topical gel USP, 0.75%. Patients may use cosmetics after application of metronidazole topical gel USP, 0.75%.

No Recall
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Metronidazole Gel | Ostl, Inc.

• Clean affected area

• Apply small amount of this product on the area 1-3 times daily

• May be covered with a sterile bandage

• If bandaged, let dry first

No Recall
Physicians Total Care, Inc.

Metronidazole Gel | Physicians Total Care, Inc.

The recommended dose is one applicator full of Metronidazole Vaginal Gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole Vaginal Gel should be administered at bedtime.

No Recall
Obagi Medical Products, Inc.

Metronidazole Gel | Obagi Medical Products, Inc.

Apply and rub in a thin film of metronidazole topical gel USP, 0.75%, twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole topical gel USP, 0.75%. Patients may use cosmetics after application of metronidazole topical gel USP, 0.75%.

No Recall
Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Metronidazole Gel | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Apply and rub in a thin film of metronidazole topical gel USP, 0.75%, twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole topical gel USP, 0.75%. Patients may use cosmetics after application of metronidazole topical gel USP, 0.75%.

No Recall
Sandoz Inc.

Metronidazole Gel | Sandoz Inc.

Apply and rub in a thin film of metronidazole gel USP, 1% once daily to affected area(s).

A gentle cleanser should be used before the application of metronidazole gel USP, 1%.

Cosmetics may be applied after the application of metronidazole gel USP, 1%.

Not for oral, ophthalmic or intravaginal use.

No Recall
Aidarex Pharmaceuticals Llc

Metronidazole Gel | Aidarex Pharmaceuticals Llc

The recommended dose is one applicator full of Metronidazole Vaginal Gel (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole Vaginal Gel should be administered at bedtime.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Metronidazole Gel | Taro Pharmaceuticals U.s.a., Inc.

Apply and rub in a thin film of metronidazole gel once daily to affected area(s).

A gentle cleanser should be used before the application of metronidazole gel. Cosmetics may be applied after the application of metronidazole gel.

Not for oral, ophthalmic or intravaginal use.

No Recall